Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Acute Pancreatitis
Both
Chronic Acute Pancreatitis
Trial Information
Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
Inclusion Criteria:
- pancreatic pseudocyst, at least 6 cm in diameter
- symptomatic pancreatic pseudocyst
- increasing size of pancreatic pseudocyst within 6 weeks
Exclusion Criteria:
- Pregnancy
- Age less than 18 years
- Postoperative status preventing access to papilla
- Allergy to contrast preventing from ERP
- Missing informed consent to study
- PTT above 1.5 times of normal, unless substituted
- Platelet count less than 50.000/µl, unless substituted
- Pancreatic ascites or fistula
- Life expectancy less than 2 years
- Percutaneously drained cysts are not part of the study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recurrence of pancreatic pseudocyst
Outcome Description:
-
Outcome Time Frame:
two years
Safety Issue:
No
Principal Investigator
Mark Ellrichmann, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
Authority:
Germany: Ethics Commission
Study ID:
UKSH-122010
NCT ID:
NCT01276002
Start Date:
January 2011
Completion Date:
June 2014
Related Keywords:
- Chronic Acute Pancreatitis
- disrupted duct
- pancreatic pseudocysts
- Pancreatic Pseudocyst
- Pancreatitis
Name | Location |
|---|
